BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U BY KOTEX CLICK

    MDR report key: 4030772 · Received August 22, 2014

    Report

    Report Number
    9611594-2014-00054
    Event Type
    Malfunction
    Date Received
    August 22, 2014
    Date of Event
    January 1, 2014
    Report Date
    July 23, 2014
    Manufacturer
    AVENT S. DE R.L. DE C.V.
    Product Code
    HEB
    PMA / PMN Number
    K113036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD IS UNDER REVIEW. INFORMATION FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND ANALYSIS. CONSUMER HAD NOT RETURNED UNUSED PRODUCT FOR EVALUATION AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THIS IS A NON-US EVENT. THE EVENT OCCURRED IN (B)(6). THE CONSUMER STATED THAT HER TAMPON CAME APART UPON REMOVAL AND TAMPON PIECES REMAINED INSIDE OF HER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509706 U BY KOTEX CLICK TAMPON HEB AVENT S. DE R.L. DE C.V. REGULAR AA334201A

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR